Quality Assurance Manager

Posted 25 Days Ago
Be an Early Applicant
Cary, IL
In-Office
111K-146K Annually
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
Lead the Quality Engineering team, oversee operations and projects, ensure compliance, drive improvements, and develop talent in a highly regulated environment.
Summary Generated by Built In
Work Flexibility: Onsite

Stryker is hiring a Quality Assurance Manager to join our Sage business in Cary, Illinois! In this role, you will lead the Quality Engineering team, including calibration oversight for the facility. You’ll ensure alignment with site and organizational goals, provide daily support to plant operations, and collaborate cross-functionally with Operations, Planning, Sourcing, HR, QC/QA, and Commercial Quality! You’ll drive departmental objectives, champion site and network initiatives, and lead continuous improvement efforts.

Additionally, you’ll empower a high-performing team by thoughtfully delegating responsibilities, ensuring robust training, and fostering a culture of accountability and growth through ongoing performance coaching and support.

What You Will Do:

  • Oversee daily operations and projects within Quality Engineering and Calibration, including setting clear objectives, planning, data analysis, cost evaluation, training, and reporting.

  • Ensure the Quality Engineering and Calibration team meets business needs through timely closure of quality investigations (NCs, CAPAs), change control approvals, process ownership, validation support, and active stakeholder collaboration.

  • Set strategic direction for the quality engineering team to ensure attainment of site and network goals.

  • Monitoring of KPIs and process measures for the assigned area of management.

  • Manage quality metrics, provide updates, and drive improvements to ensure the team meets or exceeds performance targets

  • Identify and communicate to quality leadership issues that impact product purity, quality, safety or efficacy, regulatory compliance or business continuity.

  • Identify and continually improve process effectiveness within the Cary site.

  • Ensure key site representation at external regulatory body audits.

  • Provide SME input into quality planning process and assessment of risk.

  • Develop resource planning estimates to manage project workload and productivity

  • Leading cross functional project team(s) through variety of project types including meetings for resolution of quality issues.

  • Maintain strong relationships and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, and Marketing departments to ensure corporate goals and strategies are met.

  • Attract, develop, and retain top talent and foster professional growth.

  • Maintaining current knowledge of applicable domestic and international regulations

What You Need:

  • Bachelor’s degree required; strongly preferred in Engineering, Science, or a related field.

  • 8+ years of experience working in a highly regulated environment, specifically in Quality, Manufacturing, or Engineering.

  • Experience in the Medical Device or Pharmaceutical industry.

  • 3+ years of management experience.

$110,600 - 146,4000 - 182,200 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Top Skills

Calibration
Data Analysis
Quality Engineering
Regulatory Compliance
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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

Together with our customers, we are driven to make healthcare better.

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